Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
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ClinicalTrials.gov Identifier: NCT01737216 |
Recruitment Status
: Unknown
Verified November 2012 by Hebei Tumor Hospital.
Recruitment status was: Active, not recruiting
First Posted
: November 29, 2012
Last Update Posted
: December 31, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: Zoledronic acid plus EP/TP Drug: EP/TP | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | January 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Zoledronic acid plus First-line chemotherapy |
Drug: Zoledronic acid plus EP/TP
Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
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Active Comparator: First-line chemotherapy |
Drug: EP/TP
Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
Other Name: First-line chemotherapy
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- Progression-free survival(PFS) [ Time Frame: 1 year ]
- Overall survival(OS) [ Time Frame: 3 years ]
- Bone mineral density(BMD) [ Time Frame: 1 year ]
- Quality of life(QOL) [ Time Frame: 1 year ]

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Ages Eligible for Study: | 70 Years and older (Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent form
- Age ≥70 years
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically or cytologically confirmed lung cancer
- Did not receive bisphosphonate treatment
Exclusion Criteria:
- Appear relapse and metastasis
- receive other bisphosphonate treatment
- Active or uncontrolled infection
- Pregnant or lactating women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737216
China, Hebei | |
Hebei Tumor Hospital | |
Shijiazhuang, Hebei, China, 050011 |
Principal Investigator: | Wei Liu | Hebei Tumor Hospital |
Responsible Party: | Hebei Tumor Hospital |
ClinicalTrials.gov Identifier: | NCT01737216 History of Changes |
Other Study ID Numbers: |
HBTH201 Hebei Tumor Hospital ( Registry Identifier: Hebei Tumor Hospital ) |
First Posted: | November 29, 2012 Key Record Dates |
Last Update Posted: | December 31, 2012 |
Last Verified: | November 2012 |
Keywords provided by Hebei Tumor Hospital:
Aged patients |
Additional relevant MeSH terms:
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs |